Esophageal AdenocarcinomasPhase 2NCT00216008
Pharmacogenomic Study of Docetaxel and Cisplatin, Followed by Docetaxel, Cisplatin and Irradiation.
A Phase 2 study testing docetaxel, cisplatin and radiation in people with Esophageal Adenocarcinomas and Adenocarcinomas of the Gastroesophageal Junction, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this research study is to find out the effectiveness of the experimental combination of Docetaxel, Cisplatin, and radiation therapy administered prior to the surgical removal of your esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Adenocarcinomas, Adenocarcinomas of the Gastroesophageal Junction
- What is being tested?
- docetaxel, cisplatin and radiation
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Feb 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histological or cytological confirmed esophageal adenocarcinoma or adenocarcinoma of the gastroesophageal junction (this diagnosis will be rendered by the gastroenterology endoscopist, and refers to tumors at the junction of the esophagus and the stomach, where >50% of the tumor mass is above the diaphragm). Tumors must not have greater than 2cm extension into the the cardia.
- Stage T2N0M0, T3N0M0, T1-3N1M0, T1-3N0-1M1a as determined by imaging studies and endoscopic ultrasound staging. M1a disease (celiac nodal metastasis) is permitted if other eligibility criteria are met. Any lesion suspicious for metastasis should biopsied (either by tru cut or fine needle aspiration) to prove eligibility.
- The subject has been deemed an appropriate surgical candidate by one of the surgical subinvestigators (ie. Not T4).
- No medical comorbidity making the patient not a surgical candidate.
- Subject must be 18 years or older
- Subject must understand the consent and be willing to give written and informed consent to participate in this investigational protocol, and for a tumor biopsy to be performed for research purposes at the time of their staging endoscopic ultrasound (clinically required for their care), and for a portion of their resection specimen be subjected to experimental laboratory analysis
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- ECOG performance status <1 (Karnofsky >80%; see Appendix A).
- Subjects must have adequate caloric intake, as determined by a nutrition evaluation by a registered dietician. Nutrition intake may be enteral, hyperalimentation by enteral feeding tube, or by parenteral nutrition.
- Patients must have normal organ and marrow function as defined as: leukocytes >3,000/mcL; absolute neutrophil count >1,500/mcL; platelets >100,000/mcL; hemoglobin > 8 g/dl; Creatinine clearance (estimated by Cockroft-Gault equation) >50-mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Hepatic: Total bilirubin must be < ULN; AST and ALT and alkaline phosphatase must both be less than 2.5 x ULN.
- Has a negative serum or urine pregnancy test within 7 days prior to initiation of therapy (female patients of childbearing potential).
Who cannot join
- Patients may not be receiving any other investigational agents.
- Common Toxicity Criteria Adverse Events version 3 (CTCAEv3) greater than grade 1 peripheral neuropathy.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
- Pregnant and nursing women are excluded from this study. Women / men of childbearing potential not using a reliable and appropriate contraceptive method. Woman of childbearing potential with either a positive or no pregnancy test at baseline. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). Patients will agree to continue contraception for 30 days from the date of the last study drug administration
- Patients with a history of severe hypersensitivity reaction to docetaxel, cisplatin, or drugs formulated with polysorbate (Tween) 80.
- Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with cisplatin and docetaxel or other agents administered during the study.
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- Major surgery within 4 weeks of the start of study treatment, without complete recovery.
- History of clinically significant interstitial lung disease and/or pulmonary fibrosis.
- Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.
- Clinical or radiographic evidence of a tracheobronchial fistula or invasion of the aorta (i.e. T4 disease).
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
Official title: Phase II Pharmacogenomic Study of Neoadjuvant Pre-irradiation Docetaxel and Cisplatin, Followed by Neoadjuvant Concomitant Docetaxel, Cisplatin and Irradiation, Followed by Surgery (CD-CDR-S) in Adult Patients With Operable Adenocarcinomas of the Esophagus or Gastroesophageal Junction
The purpose of this research study is to find out the effectiveness of the experimental combination of Docetaxel, Cisplatin, and radiation therapy administered prior to the surgical removal of your esophageal cancer.
Read the detailed description
This study seeks to determine the safety and efficacy (the latter based on pathologic response rate, three- and five-year survival rates) of a three-phase multi-modality approach to adenocarcinomas of the esophagus or gastroesophageal junction. This study also aims retrospectively to determine if a specific tumor gene array profile would predict for pathologic complete response. Study schema is as follows. Patients are first staged, next they receive induction Docetaxel and Cisplatin on days 1 and 22, patients are then restaged, next they will undergo radiation therapy combined with Cisplatin and Docetaxel for approximately days 42 thorough 84, patients are again restaged, and finally surgery at approximately days 100 to 150.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Secondary outcomes (3)
toxicity and tolerability of this induction strategy
time to progression
surgical complication rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionFeb 2007
- Study completionFeb 2007
Why it stopped: IRB Closure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal AdenocarcinomasStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Investigators
- Chris Garrett, MD, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216008
- Sponsor's protocol ID
- MCC-13946
- Other IDs
- USFIRB#103493, IIT 14069
- Status last verified
- Jul 2009
- First submitted
- 19 Sep 2005
- Last updated
- 25 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Pharmacogenomic Study of Neoadjuvant Pre-irradiation Docetaxel and Cisplatin, Followed by Neoadjuvant Concomitant Docetaxel, Cisplatin and Irradiation, Followed by Surgery (CD-CDR-S) in Adult Patients With Operable Adenocarcinomas of the Esophagus or Gastroesophageal Junction
- ClinicalTrials.gov ID
- NCT00216008
- Acronym / sponsor ID
- MCC-13946
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB Closure
- Enrolment
- 42 participants
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Study start
- Jul 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to find out the effectiveness of the experimental combination of Docetaxel, Cisplatin, and radiation therapy administered prior to the surgical removal of your esophageal cancer.
Detailed description
This study seeks to determine the safety and efficacy (the latter based on pathologic response rate, three- and five-year survival rates) of a three-phase multi-modality approach to adenocarcinomas of the esophagus or gastroesophageal junction. This study also aims retrospectively to determine if a specific tumor gene array profile would predict for pathologic complete response. Study schema is as follows. Patients are first staged, next they receive induction Docetaxel and Cisplatin on days 1 and 22, patients are then restaged, next they will undergo radiation therapy combined with Cisplatin and Docetaxel for approximately days 42 thorough 84, patients are again restaged, and finally surgery at approximately days 100 to 150.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have histological or cytological confirmed esophageal adenocarcinoma or adenocarcinoma of the gastroesophageal junction (this diagnosis will be rendered by the gastroenterology endoscopist, and refers to tumors at the junction of the esophagus and the stomach, where >50% of the tumor mass is above the diaphragm). Tumors must not have greater than 2cm extension into the the cardia.
- Stage T2N0M0, T3N0M0, T1-3N1M0, T1-3N0-1M1a as determined by imaging studies and endoscopic ultrasound staging. M1a disease (celiac nodal metastasis) is permitted if other eligibility criteria are met. Any lesion suspicious for metastasis should biopsied (either by tru cut or fine needle aspiration) to prove eligibility.
- The subject has been deemed an appropriate surgical candidate by one of the surgical subinvestigators (ie. Not T4).
- No medical comorbidity making the patient not a surgical candidate.
- Subject must be 18 years or older
Key exclusion criteria (10 listed)
- Patients may not be receiving any other investigational agents.
- Common Toxicity Criteria Adverse Events version 3 (CTCAEv3) greater than grade 1 peripheral neuropathy.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
- Pregnant and nursing women are excluded from this study. Women / men of childbearing potential not using a reliable and appropriate contraceptive method. Woman of childbearing potential with either a positive or no pregnancy test at baseline. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). Patients will agree to continue contraception for 30 days from the date of the last study drug administration
- Patients with a history of severe hypersensitivity reaction to docetaxel, cisplatin, or drugs formulated with polysorbate (Tween) 80.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| docetaxel | Drug | – |
| cisplatin | Drug | – |
| radiation | Procedure or surgery | – |
| surgery | Procedure or surgery | – |
Primary outcome
response rate
3 secondary outcomes
toxicity and tolerability of this induction strategy
time to progression
surgical complication rate
Results and safety
The study was stopped early (reason given: IRB Closure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Garrett, MD principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing docetaxel, cisplatin and radiation in people with Esophageal Adenocarcinomas and Adenocarcinomas of the Gastroesophageal Junction, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: IRB Closure). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.